Palisade Bio's PALI-2108 Advances Toward Clinical Study Launch
Update on PALI-2108 Phase 1 Clinical Study
– Completion of nonclinical safety and toxicity studies, Phase 1 clinical trial design, and established Maximum Recommended Starting Dose.
– Completion of pre-Clinical Trial Application (CTA) meeting with Health Canada.
– Submission of the CTA for the Phase 1 clinical study involving normal healthy volunteers and ulcerative colitis patients.
– On track towards clinical site initiation and dosing of the first patient in the Phase 1 human clinical study before year end.
Overview
Palisade Bio, Inc. (NASDAQ: PALI) recently shared exciting news regarding its lead program, PALI-2108, which focuses on the treatment of ulcerative colitis (UC). This biopharmaceutical company is dedicated to developing novel solutions for patients suffering from autoimmune, inflammatory, and fibrotic diseases.
The PALI-2108 treatment is a locally activated PDE4 inhibitor prodrug specifically targeted at individuals with moderate to severely active UC. The innovative approach incorporates machine learning to identify a critical level of increased PDE4B expression in over 1,600 patients grouped from ten studies. This research shows that more than 70% of identified patients exhibit this over-expression, which presents an opportunity for an FDA-approved test. This breakthrough could help in selecting the most suitable patients for PALI-2108 treatment, aiming for enhanced therapeutic efficacy.
Palisade is also working on a second methodology by utilizing six PDE4-related biomarkers that have outperformed existing benchmark tests in assessing PDE4 inhibition. This targeted solution is designed to improve therapeutic outcomes, exemplifying Palisade Bio’s commitment to advancing the field of precision medicine focused on UC.
Significant Progress Announced
Dr. Mitch Jones, Chief Medical Officer of Palisade Bio, reflected on the importance of these advancements: “We are excited to announce significant progress in our development of precision medicine tests designed to optimize treatment for moderate to severely active UC patients. Our PALI-2108 program has made notable strides, and we are eager to see the clinical applications unfold.” He highlighted that UC presents a significant challenge, and there is a critical need for effective treatments that achieve remission while ensuring improved safety profiles.
The clinical study for PALI-2108 has been designed as a single-center, double-blind, placebo-controlled trial. This study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics among healthy volunteers, as well as a patient cohort with UC. Approximately 90 participants are expected to be enrolled across multiple cohorts focusing on different aspects of the treatment.
Palisade is also aiming to evaluate the pharmacokinetics of its metabolites, including PALI-0008 and PALI-0708. These evaluations will measure how food intake influences the pharmacokinetics of PALI-2108, ensuring a comprehensive understanding of its effects. The study’s primary goal revolves around safety and tolerability, which are critical components in developing new therapeutics.
Collaboration with Health Authorities
In a proactive measure, the company recently engaged in a pre-CTA consultation meeting with Health Canada. This strategic discussion focused on the design of the Phase 1 program involving normal healthy volunteers. The insights gained from this meeting are expected to facilitate a robust submission of the CTA for PALI-2108.
About Palisade Bio
Palisade Bio continues to drive innovation in biopharmaceuticals dedicated to individuals affected by autoimmune, inflammatory, and fibrotic diseases. The company’s targeted therapeutic approach aims to redefine treatment paradigms and improve patient outcomes. For more details about Palisade Bio’s initiatives and updates, please visit their official website.
Frequently Asked Questions
What is the primary goal of the PALI-2108 study?
The main objective is to evaluate the safety and tolerability of PALI-2108 among healthy volunteers and UC patients.
How many patients will be enrolled in the PALI-2108 study?
Approximately 90 patients are expected to be enrolled across various study cohorts.
What conditions does PALI-2108 aim to treat?
PALI-2108 is designed to treat moderate to severely active ulcerative colitis.
What are the unique features of the PALI-2108 treatment?
It is a locally activated PDE4 inhibitor prodrug, leveraging machine learning for precision medicine.
How does Palisade Bio ensure the effectiveness of its treatments?
The company focuses on optimizing patient selection and analyzing biomarkers to enhance treatment outcomes.
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